Pouring container with double cap protector for sterile dispensing lip

ABSTRACT

A sterile medical liquid container with a pouring lip at a dispensing neck that is closed by an inner cap and an outer cap nested together. These caps have concentric skirts with transverse sterile lower end surfaces thereon. The outer cap has an external annular seal member that hermetically joins to the container for encasing the sterile lower end surfaces of both skirts. This structure reduces the chance of contamination being transferred from the outer cap to the inner cap and then to the pouring lip when the container is opened.

Dec. 2, 1975 X R 00 B 5 2 3,393,818 7/1968 McIntosh.............................. 3,394,831 7/1968 Bathish 3,730,372 5/1973 Komindowski POURING CONTAINER WITH DOUBLE CAP PROTECTOR FOR STERILE DISPENSING LIP [75] Inventors: Pradip V. Choksi, North Hollywood;

Primary ExaminerHerbert F. Ross Steldley Seal Beach both of Attorney, Agent, or FirmLarry N. Barger; Robert T. Cahf' Merrick American Hospital Supply Corporation, Evanston, Ill.

Mar. 7, 1973 Appl. No.: 338,672

[73] Assignee:

[22] Filed:

A sterile medical liquid container with a pouring lip at a dispensing neck that is closed by an inner cap and an outer cap nested together. These caps have concentric skirts with transverse sterile lower end surfaces thereon. The outer cap has an external annular seal member that hermetically joins to the container for own 1 .PIUNAW mZM 5. 6 25 in l2" /2 5 u 2. m 3 m 5 U 2 u u 5 n l u 2 m C G S L U m N H 5 5 encasing the sterile lower end surfaces of both skirts. This structure reduces the chance of contamination [58'] Field of Search.......... 215/1 C, 42, 37 R, 46 A,

215/DIG. 3, 250, 253; 220/27; 401/132, 133

be ng transferred from the outer cap to the inner cap and then to the pouring lip when the container is opened.

[56] References Cited UNITED STATES PATENTS 12/1938 Burke 215/42 11 Claims, 4 Drawing Figures U.S. Patent Dec. 2, 1975 Sheet 1 of2 3,923,185

Free

sheet 2 of: 3,923,185

U.S. Patent Dec. 2, 1975 BACKGROUND through an administration set into the patients veins.

Another commonly used procedure dispenses sterile medical liquid, such as normal saline or sterile water, to flush a surgical wound. The physician often does this simply by pouring sterile liquid from a l or 2 liter container into the surgical wound. These later type containers are called pouring containers.

The protection of the sterile dispensing outlet of intravenous (I.V.) solution containers and pouring containers provide different problems. In the I.V. solution container the bottle neck has a closure protecting the neck during dispensing. The closure is connected to a hollow spike or other adapter of an I.V. administration set through which the solution slowly drains. The pouring container, on the other hand, must dispense a very large amount of liquid quickly. Thus, it has a large exposed open mouth, 1 to 1% inches (2.5 to 3.8 centimeters) diameter, surrounded by a sterile lip. This lip is contacted and wetted with the sterile liquid contents being poured from the container.

Various closures for I.V. solution containers have been proposed in the past that include double and triple closure systems. However, these I.V. closure systems do not really solve the problem of maintaining the sterile integrity of -a large diameter pouring lip while providing a closure that is easy to open.

SUMMARY OF THE INVENTION This invention provides a special closure system that alleviates the problem of maintaining a sterile pouring lip at a dispensing neck of a pouring container. The special closure system has an inner cap and an outer cap nested together, and these caps have skirts with transverse sterile lower end surfaces. An annular seal structure external to the sterile lower end surfaces of both skirts seals the outer cap to the container until the seal is broken apart. When the closure is opened the sterile lower end surface of the outer cap can contact the inner cap without contaminating it. Likewise, the sterile lower end surface of the inner cap skirt can contact the sterile dispensing lip without contaminating it. This structure reduces the chance of contamination being transferred from the outer cap to the inner cap and then to the dispensing lip when the container is opened immediately before use.

THE DRAWINGS FIG. 1 is a front elevational view of the pouring container with the double cap closure system as it is shipped, stored and ready for use;

FIG. 2 is an enlarged sectional view taken vertically through a top portion of the pouring container showing its outer cap being removed from the inner cap;

FIG. 3 is a sectional view of the top portion of the pouring container showing the double cap closure system as it would appear in FIG. 1 prior to opening; and

FIG. 4 is a perspective view showing liquid pouring from the container after the inner and outer caps have been removed.

DETAILED DESCRIPTION In FIG. 1 the pouring container is shown to include a bottle 1 and a closure system 2. The bottle includes a dispensing neck surrounded by a flange 3 at its upper end and a hinged hanging tab 4 at its lower end. This hanging tab 4 is an optional feature of the pouring container and can be used to suspend the container mouth downwardly. However, usually the hanging tab 4 is not used and the pouring container is completely emptied while held in a physicians hand. To facilitate handling the bottle an indented waist 5 is shown.

The enlarged sectional view of FIG. 2 gives a detailed illustration of the closure system. Here the bottle 1 with a neck 6 surrounded by flange 3 terminates at an upper end in a sterile pouring lip 7. It is this pouring lip 7 that is very critical. This invention is designed to protect the sterile integrity of the pouring lip 7.

Protecting the lip 7 and neck 6 is an inner cap 8. This inner cap 8 has a top wall 9 and a skirt 10. The top wall has an integral compressible rib 21 that hermetically seals against lip 7. At a lower end of skirt 10 is a lower end surface that is very critical to this invention. This lower end surface 11 is maintained in a sterile condition. Thus, when the inner cap 8 is removed, lower end 11 of skirt 10 can scrape across sterile dispensing lip 7 without contaminating it.

Fitting over inner cap 8 is an outer cap 12. This cap 12 includes a top wall 13 and a skirt 14. Like inner cap 8 the outer cap has a lower end surface 16 of skirt 14 j that is maintained in a sterile condition, and is positioned below the lower end 14 of the inner cap skirt. Extending outwardly from bottom skirt surface 14 is a frangible brim 17 on outer cap 12. In FIG. 2, frangible brim 17 has just been broken apart from an annular fused portion 18 of brim 17. The brim 17 is substantially thinner than the skirt 14 and is from 0.005 to 0.050 inch (0.127 to 1.27 mm.) thick. The fracture line of the brim 17 is at an annular weakened section of the brim that is external of the sterile lower end surface 16 of the outer cap skirt 14. Therefore, when the outer cap is broken away as shown in FIG. 2 the inner surface of the skirt 14 and lower end surface 16 can contact the critical outer surface of the inner caps skirt 10 without contaminating it.

Various means can be used to break the annular hermetic seal formed by frangible brim 17. In FIG. 2 an annular jacking ring 15 has internal threads 19 that are threadingly disposed on external threads 20 of outer cap skirt 14. Preferably, these threads are left-handed so that counter clockwise motion of the jacking ring will pry the frangible brim from flange 3 of the bottle to break it apart. Since both of the lower end surfaces of the skirts are encased and enclosed by the annular hermetic seal shown as a frangible brim, these lower skirt end surfaces are not exposed to contamination by handling and shipping and storing. Also, when the container is steam sterilized there is no contact of the steam with the sterile lower skirt surfaces of either the inner or outer cap.

In FIG. 3 the double cap closure system with protected sterile lower end surfaces is shown as it is shipped and stored in a hospital ready for use. The

broad transverse surfaces 11 and 16 are indicated as sterile in FIG. 3.

After the inner and outer caps have been removed from the FIG. 3 version the pouring container is then ready for dispensing its sterile liquid contents. The dispensing step is shown generally in FIG. 4. Unlike a parenteral solution bottle that has a cap or rubber stopper protecting its bottle lip, the pouring container has a lip 7 that is exposed to liquid contact and is wetted by this liquid which then enters a surgical wound or the like. This is why it is extremely critical to keep the dispensing lip of a pouring container sterile.

In the special double cap closure system mentioned above, exceptionally good results can be obtained when the bottle is semirigid and blowmolded of a propylene-ethylene copolymer thermoplastic material called a polyallomer. One such material is marketed by Eastman Chemical Company under the name TENITE. The outer cap is injection molded and is fusion bonded externally of its sterile lower surface 16. This creates a homogeneous thermoplastic shell of the fused outer cap and bottle. A jacking ring can be made of rigid thermoplastic material. Also, if desired, other means for opening the sterile annular seal between the outer cap and bottle can be used.

In the foregoing specification a specific-example has been used to describe the invention. However, it is understood by those skilled in the art that certain modifications can be made to this embodiment without departing from the spirit and scope of the invention.

We claim:

1. A container and double closure providing a system for storing and dispensing sterile liquids, which system includes a blow molded thermoplastic container with a dispensing outlet, an inner closure, an outer cap, and a jacking ring, the container and outer cap forming a unit that has transverse abutment means surrounding the outlet, wherein the improvement comprises:

a threaded tubular container neck with a pouring lip surrounding the dispensing outlet; a manually removable inner cap being said inner closure with an internally threaded skirt that has a lower end surface, and this inner cap is threadingly disposed on the tubular neck; said outer cap being a separately formed injection molded cap with a longitudinal axis, said outer cap having both a thin frangible section and externally exposed threads, and said outer cap has a skirt and is sealed to the container proximate the abutment means with an annular bacteria-tight bond to form a hermetically sealed enclosure which encases the inner cap including the lower end surface of the inner cap skirt, and the threads of the outer cap are in axial alignment with the abutment means, whereby said outer cap threads can receive said jacking ring and guide it toward the abutment means for exerting a pressure against the abutment means to axially pry the outer cap apart at its frangible section.

2. The combination as set forth in claim 1, wherein the outer cap has an integral external brim that is heat fused to the thermoplastic container.

3. The combination as set forth in claim 1, wherein the threads on the outer cap are left-handed.

4. The combination as set forth in claim 1, wherein said jacking ring is internally threaded and threadingly disposed on the outer cap for rupturing the outer cap by exerting an axial force between the outer cap threads and the abutment means.

5. The combination as set forth in claim 1 wherein the container has a flange as the abutment means and the frangible section of the outer cap has an externally extending frangible brim with an outer annular portion fused to said flange and an inner annular portion unfused to the flange with a weakened fracturable line between the fused and unfused portions, said unfused portions defining a lower end surface of the outer cap skirt which is encased within the hermetically sealed unit.

6. The combination as set forth in claim 5, wherein the brim has a thickness substantially less than the thickness of the outer cap skirt.

7. The combination as set forth in claim 5 wherein the lower end surface of the outer cap skirt is positioned below the lower end surface of the inner cap when the container is positioned outlet upward.

8. The combination as set forth in claim 5, wherein said jacking ring is threadingly disposed on the outer cap threads and this jacking ring is located externally of the lower end surfaces of both the inner and outer caps.

9. The combination as set forth in claim 1 wherein the inner cap includes a compressible annular internal rib that sealingly engages the pouring lip to form a hermetic seal thereat prior to removal of the inner cap.

10. The combination as set forth in claim 1 wherein the outer cap and bottle are of a propylene-ethylene copolymer thermoplastic material.

11. A container with inner and outer closures for storing and dispensing sterile liquids which includes a thermoplastic bottle with a dispensing outlet, and said bottle and outer closure form a unit that has a transverse abutment means surrounding the outlet, wherein the improvement comprises:

a threaded tubular bottle neck with a pouring lip surrounding the dispensing outlet; a separately formed thermoplastic outer cap having both a thin frangible section and externally exposed threads, which outer cap is hermetically fused to the bottle proximate the abutment means to provide a sealed thermoplastic shell that has the outer cap threads in axial alignment with said abutment means for guiding an opening member toward said abutment means to rupture the outer cap at its frangible section; and an inner cap including a top wall. a threaded skirt and a lower end of the skirt, which inner cap is threadingly disposed on the threaded bottle neck with all of these inner cap components encased within the thermoplastic shell. 

1. A container and double closure providing a system for storing and dispensing sterile liquids, which system includes a blow molded thermoplastic container with a dispensing outlet, an inner closure, an outer cap, and a jacking ring, the container and outer cap forming a unit that has transverse abutment means surrounding the outlet, wherein the improvement comprises: a threaded tubular container neck with a pouring lip surrounding the dispensing outlet; a manually removable inner cap being said inner closure with an internally threaded skirt that has a lower end surface, and this inner cap is threadingly disposed on the tubular neck; said outer cap being a separately formed injection molded cap with a longitudinal axis, said outer cap having both a thin frangible section and externally exposed threads, and said outer cap has a skirt and is sealed to the container proximate the abutment means with an annular bacteria-tight bond to form a hermetically sealed enclosure which encases the inner cap including the lower end surface of the inner cap skirt, and the threads of the outer cap are in axial alignment with the abutment means, whereby said outer cap threads can receive said jacking ring and guide it toward the abutment means for exerting a pressure against the abutment means to axially pry the outer cap apart at its frangible section.
 2. The combination as set forth in claim 1, wherein the outer cap has an integral external brim that is heat fused to the thermoplastic container.
 3. The combination as set forth in claim 1, wherein the threads on the outer cap are left-handed.
 4. The combination as set forth in claim 1, wherein said jacking ring is internally threaded and threadingly disposed on the outer cap for rupturing the outer cap by exerting an axial force between the outer cap threads and the abutment means.
 5. The combination as set forth in claim 1 wherein the container has a flange as the abutment means and the frangible section of the outer cap has an externally extending frangible brim with an outer annular portion fused to said flange and an inner annular portion unfused to the flange with a weakened fracturable line between the fused and unfused portions, said unfused portions defining a lower end surface of the outer cap skirt which is encased within the hermetically sealed unit.
 6. The combination as set forth in claim 5, wherein the brim has a thickness substantially less than the thickness of the outer cap skirt.
 7. The combination as set forth in claim 5 wherein the lower end surface of the outer cap skirt is positioned below the lower end surface of the inner cap when the container Is positioned outlet upward.
 8. The combination as set forth in claim 5, wherein said jacking ring is threadingly disposed on the outer cap threads and this jacking ring is located externally of the lower end surfaces of both the inner and outer caps.
 9. The combination as set forth in claim 1 wherein the inner cap includes a compressible annular internal rib that sealingly engages the pouring lip to form a hermetic seal thereat prior to removal of the inner cap.
 10. The combination as set forth in claim 1 wherein the outer cap and bottle are of a propylene-ethylene copolymer thermoplastic material.
 11. A container with inner and outer closures for storing and dispensing sterile liquids which includes a thermoplastic bottle with a dispensing outlet, and said bottle and outer closure form a unit that has a transverse abutment means surrounding the outlet, wherein the improvement comprises: a threaded tubular bottle neck with a pouring lip surrounding the dispensing outlet; a separately formed thermoplastic outer cap having both a thin frangible section and externally exposed threads, which outer cap is hermetically fused to the bottle proximate the abutment means to provide a sealed thermoplastic shell that has the outer cap threads in axial alignment with said abutment means for guiding an opening member toward said abutment means to rupture the outer cap at its frangible section; and an inner cap including a top wall, a threaded skirt and a lower end of the skirt, which inner cap is threadingly disposed on the threaded bottle neck with all of these inner cap components encased within the thermoplastic shell. 